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U.S. Department of Health and Human Services

About FDA

Engage in the World Health Organization (WHO) pre-qualification of diagnostics pilot programme for HIV

Description: The WHO prequalification of diagnostics programme aims to increase access to affordable diagnostic technologies of assured quality that are appropriate for use in resource limited settings. FDA’s Office of Blood Research and Review (OBRR) voluntarily provides scientific review input to the WHO regarding HIV test dossiers.

FY 2013 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

No updates to report against this initiative during the quarter.

Quarter 1

Completed Quarter 1

Waiting for WHO to send dossier for FDA to review.

Quarter 2

Completed Quarter 2

Currently WHO is in the process of revising their re-qualification programs; review of the dossiers for HIV diagnostic tests are on hold.

Quarter 3

Completed Quarter 3

The entire pre-qualification program at WHO (for vaccines, medicines, IVDs) is being re-evaluated and restructured.  OBRR will proceed with the commitment that has already been made for evaluation of an HIV dossier when made available. 

Quarter 4

Completed Quarter 4

FY 2014 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

No updates to report against this initiative during the quarter.

Quarter 1

Completed Quarter 1

The Deputy Director for OBRR/DETTD participated in a meeting at WHO (March 31 to April 4, 2014) that was convened to finalize the program.

Quarter 2

Completed Quarter 2

 

Quarter 3

 

Quarter 4

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.